About this trial
Kidney stone disease is a common condition, and retrograde intrarenal surgery (RIRS) is a minimally invasive procedure frequently used to remove kidney stones. During RIRS, pressure inside the kidney can increase, which may contribute to temporary kidney injury. New aspiration-enabled access sheath systems have been developed to better control this pressure by continuously removing irrigation fluid during surgery. This study will compare aspiration and conventional access sheath systems to determine whether improved pressure control reduces early kidney injury. Blood and urine biomarkers (IL-18 and L-FABP), which can detect kidney damage earlier than standard kidney function tests, will be measured before and after surgery. The results may help identify surgical techniques that better protect kidney function and improve the safety of kidney stone treatment for patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being 18 years of age or older
Having a planned RIRS operation
Providing written informed consent
Disqualifiers
Patients who do not give consent
Patients who will undergo combined surgery
Patients who have previously undergone endoscopic stone surgery
Being under 18 years of age
Trial design
Parallel
Treatments tested in this trial
flexible and navigable ureteral access sheath
DevicePatients of RIRS operated with flexible and navigable ureteral access sheath
conventional ureteral access sheath
DevicePatients of RIRS operated with conventional ureteral access sheath
Treatment groups
Trial outcomes
Primary outcomes
acute kidney injury
Serum IL-18 and L-FABP levels at the stated timelines.
Sponsors and contacts
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